Applied News

Category: CGMP

Do you have written procedures? (SOP, Policy and Procedure Manual)

October 24, 2013 by Kristen Cifranic

WRITTEN PROCEDURES Section 211.100(a b) All firms are expected to establish and follow detailed written procedures covering all aspects of their operation to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. These written procedures, including any changes, are to be reviewed, signed, dated, and approved by the firms quality control unit. In addition, it does little good to enact new procedures and controls if they are not read, understood, and followed by all employees, and readily available. There cannot be different standards of quality of drug products for large and small manufacturers. Written procedures regardless of the size or complexity of the operation must be established. They provide a basis for the uniform performance of a function, and they provide a step-by-step description on how to perform a specific task, function, or operation. Applied has policy and procedure manuals for gas to gas, liquid

Posted in SOP, CGMP, Tips And Tricks, FDA

Training Time!

September 23, 2013 by Victoria Marquard-Schultz

Its Training Time! Heres A Break Down When You Should Be Training! Within 90 Days of hire If youve got a new hire, youll need DOT training within 90 days! FDA requires cGMP training, too, before you can let your new filler out on his own. Check out below for the training hell need. (But wait! If your new hire came with documented training, you wont need to re-train.) Annually and on a Continuing Basis Personnel training in Current Good Manufacturing Processes is required by law. (21 CFR 211.25) The Code of Federal Regulations and the FDA require that employees manufacturing, processing, packing or handling the drug have this training as it relates to the employees job function. This training must also be given on a frequent and continuing basis and be documented. A popular option for a variety of training are online classes in cGMP and our FDA Filling on Demand Online Course Certifications (or get the classes a la carte if you only have a few employees.) Every 3 Years The

Posted in Training, DOT, FDA, CGMP

What is cGMP and why is it important?

September 05, 2013 by Kristen Cifranic

The Food, Drug and Cosmetic Act states that a drug, such as medical oxygen is adulterated and subject to legal action if it is not manufactured in accordance with the current good manufacturing practices (CGMPs), or does not comply with appropriate official standards such as strength and quality as cited in the United States Pharmacopoeia/National Formulary (U.S.P./NF). So what does that mean to Oxygen Providers? Heres an example. Terry, who owns a struggling home health care business in a ruralarea, decides to save money by supplying his patients with industrial oxygen rather than the more costly medical oxygen. He has a local welding distributor deliver industrial oxygen cylinders to his garage where he removes the cylinder labels, places the unlabeled cylinders in the bed of his pickup truck, and delivers them to patients. One of Terrys patients is severely injured from breathing oxygen contaminated with acetylene gas. The FDA is notified and with the aid of U. S. Marshals seizes

Posted in CGMP, Supplying Medical Oxygen

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